“Ninety-nine percent of people or organizations that commented on a government proposal to allow the drug industry to misinform doctors about potential risks of medications oppose the plan,” states a Public Citizen press statement, released after the organization analyzed the public comments.
“The draft guidance, issued in June 2014, would give companies that believe that the FDA-approved labeling information overstates risks free rein to tell doctors that the risks are lower,” says the press release. “Company salespeople could inform physicians of the purportedly lower risks by distributing peer-reviewed articles – without the agency seeing the articles, reviewing the data or approving them – and discuss with doctors the information about the ‘lower’ risks.”
“As most of the comments stated, this proposed guidance is reckless and seriously undermines FDA authority,” Public Citizen’s Sidney Wolfe says in the press release. “The FDA is supposed to be the government shield that protects patients when the industry pushes products that might not have a favorable benefit-to-risk ratio in order to line their own pockets. This guidance completely undermines that safety shield.”
99 Percent of Commenters Agree: FDA Proposed Guidance Is a Bad Idea, Undermines Purpose of FDA and Puts Patients at Risk (Public Citizen press release, March 11, 2015)